Find Director of regulatory affairs Jobs in Dublin County Dublin

Director, Regulatory Affairs Medical Devices & Combination Product
Takeda Pharmaceutical —Dublin, County Dublin
- €116,800–€160,600 a year
- Full-time
- English
- Bachelor's degree
- Communication skills
Senior Director, Actuarial & Regulatory Affairs - Pricing & Underwriting
Optum —Dublin, County Dublin
- Full-time
- Bachelor's degree
- No degree
- AI
Executive Director, Global Patient Safety Sciences Delivery
Regeneron —Dublin, County Dublin
- €172,500–€288,300 a year
- Doctoral degree
- Master's degree
- Business
- Annual leave
Associate Director, Regulatory Affairs - Pricing & Underwriting
Optum —Dublin, County Dublin
- Full-time
- Master's degree
- Analysis skills
- Presentation skills
4d
Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
- Bachelor's degree
- No degree
- In-person
- Annual leave
Director Regulatory Affairs Global CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Project management
- Mentoring
- Manufacturing
Executive Director, Worldwide Operations Office - Pharmacovigilance
Regeneron —Dublin, County Dublin
- €172,500–€288,300 a year
- Master's degree
- Bachelor's degree
- AI
- Annual leave
Director, European and UK Public Policy
Whatnot —Dublin, County Dublin
- €200,000–€276,000 a year
- Full-time
- Hybrid work
- Communication skills
- Work from home
Director, Portfolio Scientific Communications
Novartis —Dublin, County Dublin
- €103,845–€192,855 a year
- Full-time
- Hybrid work
- English
- Patient care
- Leadership
4d
Director Regulatory CMC Sciences Project Management
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Project management
- Mentoring
Director Regulatory Compliance (Process Excellence)
Viatris —Northern Cross, County Dublin
- Full-time
Director of Corporate Affairs
Eirgrid —Dublin, County Dublin
- Leadership
Quick apply
3d
Director Respiratory Regulatory CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Project management
- Manufacturing
Associate Director, External Manufacturing and Supply
Cytokinetics —Dublin, County Dublin
- Engineering
- ERP systems
- Bachelor's degree
Employment Counsel
Intel —Leixlip, County Kildare
- €73,600–€142,500 a year
- Full-time
- In-person
- Manufacturing
5d
Manager, External Manufacturing and Supply
Cytokinetics —Dublin, County Dublin
- Engineering
- ERP systems
- Bachelor's degree
FDI Tax, Director - Dublin
PwC —Dublin, County Dublin
- Full-time
Staff Nurse
Nazareth Care Ireland —Dublin, County Dublin
- Full-time
- Free parking
- Employee assistance program
Quick apply

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Director, Regulatory Affairs Medical Devices & Combination Product

Takeda Pharmaceutical -
Dublin, County Dublin

Apply Now

Job details

Full-time
€116,800–€160,600 a year

Qualifications

English
Bachelor's degree
Communication skills

Full job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVES:

Acts as the Person Responsible for Regulatory Compliance (PRRC) RA for Takeda’s medical devices within Takeda´s EU Authorised Representative organization per EU Medical Device Regulation (MDR) 2017/745.

The RA PRRC of the EU Authorised Representative is responsible for ensuring that the tasks of the AR are fulfilled in the context of regulatory requirements

Manages the liaisons to key regulatory authorities (e.g. notified bodies, competent authorities and others as required) in the European Economic Area (EEA), and others as needed

ACCOUNTABILITIES:

The PRRC RA role supports the EU Authorised representative duties, such as reviewing and verifying that the technical documentation and Declaration of Conformity are up-to-date and ensures that the documentation is aligned with appropriate regulatory requirements and standards

Verifies that device registration has been appropriately conducted

Other AR responsibilities per EU MDR 2017/745 Art. 11 may be in scope for this role

Prepares the application and submits the documentation to the Notified Body for both medical devices and combination products

Approves costs, handles budget and POs for product specific projects for Notified Body

Ensures that Takeda complies with all applicable regulatory requirements for medical devices within the European Economic Area (EEA), while ensuring high standards of quality and safety.

Proactively monitor regulatory changes in the EEA and updates, and supports necessary adjustments to maintain regulatory compliance across Business Units for medical devices and combination products.

Utilizes technical device knowledge, regulatory expertise and global regulatory lessons learned to shape EEA regulatory best practices, drive internal consistency and influence effective change management

Accountable to deliver on EEA strategies across Business Units and driving consistency and efficient processes to deliver on launches, regulatory change and authority and legal requests.

Provides technical, strategic and tactical regulatory guidance to product teams by defining and optimizing EEA regulatory strategies pertaining to the development, registration, commercialization and life cycle management of assigned products

Proactively identifies, analyses and manages combination product and device-related regulatory risks, ensuring timely communication with relevant stakeholders and management

Informs strategy for device-related and combination product aspects of EEA regulatory submissions (e.g., CE-marking, Notified Body Opinions, Variations, etc.)

Builds and manages strong working relationships through active partnering with key internal and external stakeholders

Provides EEA regulatory input and guidance on product-compliance related activities including change controls, deviations, and investigations

Responsible for authoring regional specific documentation for medical devices and combination products (e.g. Essential Principles Checklist per Australian requirements).

Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labeling, etc) to ensure effective strategies are developed and project execution is on target

May serve as mentor to other GRA Device Regulatory staff members

Responsible for demonstrating Takeda leadership behaviours

Lead and attend applicable industry associations

Provide necessary audit support from a device regulatory perspective

Other global responsibility & markets may be in scope for this role pending on need

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

BS/BA Degree from an EU Member State in a Scientific Discipline

10+ years of Regulatory Medical Device experience for EU and international markets. Experience as a Device regulatory lead for drug-device combination products (drug-delivery products) is preferred.

Experience working on cross-functional submission teams

Solid understanding of scientific principles and regulatory requirements relevant to global drug-device combination product development, registration and post-market support

Demonstrated track record of successful interactions with Notified Bodies and other global health authorities, including device submissions. EMA interactions and submissions, specifically related to Combination Products and Drug-Delivery experience (i.e., Notified Body Opinions, etc.) is preferred

Able to identify, prioritize and resolve issues of critical importance; provide sound regulatory advice and make informed decisions on regulatory issues for which there may not be clear/specific regulatory guidance

Demonstrate leadership, problem-solving ability, flexibility and teamwork

Exercise good judgement in elevating and communicating actual or potential issues to line management

Excellent written and oral communication skills required

Ability to partner and influence key stakeholders.

Expert knowledge of regulatory requirements (e.g. MDR, drug-led combination products) and ability to translate regulations into clear data requirements

Ability to persuasively communicate with notified bodies technical reviewers and EU Heath Authorities

A strong results-orientation, organised and a keen sense of urgency

Fluent in English (required) and in another European language (desired)

TRAVEL REQUIREMENTS:

Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

Requires approximately 10-30% travel

Locations

Dublin-Baggot Street, Ireland

Base Salary Range:

€116,800.00 - €160,600.00

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Apply Now

Refine Your Search

director of regulatory affairs jobs in dublin county dublin

Director, Regulatory Affairs Medical Devices & Combination Product

Senior Director, Actuarial & Regulatory Affairs - Pricing & Underwriting

Executive Director, Global Patient Safety Sciences Delivery

Associate Director, Regulatory Affairs - Pricing & Underwriting

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Director Regulatory Affairs Global CMC

Executive Director, Worldwide Operations Office - Pharmacovigilance

Director, European and UK Public Policy

Director, Portfolio Scientific Communications

Director Regulatory CMC Sciences Project Management

Director Regulatory Compliance (Process Excellence)

Director of Corporate Affairs

Director Respiratory Regulatory CMC

Associate Director, External Manufacturing and Supply

Employment Counsel

Manager, External Manufacturing and Supply

FDI Tax, Director - Dublin

Staff Nurse

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